Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04955990
Registration number
NCT04955990
Ethics application status
Date submitted
29/06/2021
Date registered
9/07/2021
Date last updated
18/04/2023
Titles & IDs
Public title
A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants
Query!
Scientific title
An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity
Query!
Secondary ID [1]
0
0
67896062PAH4005
Query!
Secondary ID [2]
0
0
CR109007
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CARE PAH
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - PAH Therapies
Experimental: Participants with PAH - Participants with pulmonary arterial hypertension (PAH) who newly initiate any PAH therapy(ies) at the index date (date when a participant starts the first new PAH therapy after baseline assessments) in a routine clinical setting, either as first-line therapy, as replacement therapies, as concomitant with other PAH therapies, or have already been receiving macitentan 10 milligrams (mg) for at least 3 months prior to the index date. The primary data source for this study will be the medical records of each participant.
Treatment: Drugs: PAH Therapies
PAH therapies will be administered in a routine clinical setting and data will be collected from participants who newly initiate any PAH therapy(ies), or have already been receiving macitentan 10 mg for at least 3 months prior to the index date. Participants will receive PAH therapies such as Macitentan, Ambrisentan, Bosentan, Tadalafil, Sildenafil, Riociguat, Selexipag, Epoprostenol, Iloprost, Treprostinil, and Beraprost.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to all Cause Death
Query!
Assessment method [1]
0
0
Time to all cause death will be reported. All-cause death defined as deaths due to any cause.
Query!
Timepoint [1]
0
0
Up to 6 years
Query!
Primary outcome [2]
0
0
Time to Death due to Pulmonary Arterial Hypertension (PAH) or First Hospitalization due to PAH
Query!
Assessment method [2]
0
0
Time to death due to PAH or first hospitalization due to PAH will be reported.
Query!
Timepoint [2]
0
0
Up to 6 years
Query!
Secondary outcome [1]
0
0
Time to Death due to PAH
Query!
Assessment method [1]
0
0
Time to death due to PAH will be reported.
Query!
Timepoint [1]
0
0
Up to 6 years
Query!
Secondary outcome [2]
0
0
Time to First all-cause Hospitalization
Query!
Assessment method [2]
0
0
Time to first all-cause hospitalization will be reported.
Query!
Timepoint [2]
0
0
Up to 6 years
Query!
Secondary outcome [3]
0
0
Time to First Morbidity/Mortality Event
Query!
Assessment method [3]
0
0
Time to first morbidity/mortality event will be reported. All-cause death, non-planned hospitalization due to PAH (including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins), PAH-related disease progression, defined as (both criteria must be satisfied): At least 15 percent (%) decrease in 6-minute walking distance (6MWD) from baseline or therapy change visit, and initiation of additional PAH therapy or worsening of World Health Organization (WHO) functional class (FC) will be collected for morbidity/mortality events assessment.
Query!
Timepoint [3]
0
0
Up to 6 years
Query!
Secondary outcome [4]
0
0
Time to Clinical Worsening
Query!
Assessment method [4]
0
0
Time to clinical worsening will be reported. All-cause death, non-planned hospitalization due to PAH (including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins), PAH-related deterioration identified by at least 1 criterion: worsening of WHO FC, deterioration by at least 15% in exercise capacity, as measured by the 6MWD, any signs or symptoms of right-sided heart failure will be collected for clinical worsening assessment.
Query!
Timepoint [4]
0
0
Up to 6 years
Query!
Secondary outcome [5]
0
0
Medical Resource Utilization
Query!
Assessment method [5]
0
0
Number per year of all-cause and PAH-related hospitalizations; number per year of in-patient hospital days for all causes and PAH-related causes; number per year of emergency room visits for all causes and for PAH-related causes that do not result in hospital admittance will be collected for assessment of medical resource utilization.
Query!
Timepoint [5]
0
0
Up to 6 years
Query!
Secondary outcome [6]
0
0
Change from Baseline in 6-minute Walk Distance (6MWD)
Query!
Assessment method [6]
0
0
Change from baseline in 6MWD according to non-invasive criteria will be assessed as per the low (greater than [>] 440 meters [m]), intermediate (165-440m), and high-risk category (less than [<] 165m).
Query!
Timepoint [6]
0
0
Baseline up to 6 years
Query!
Secondary outcome [7]
0
0
Change from Baseline in World Health Organization (WHO) Functional Class (FC)
Query!
Assessment method [7]
0
0
Change from baseline in WHO FC according to non-invasive criteria will be assessed as per the low (I, II), intermediate (III), and high-risk category (IV).
Query!
Timepoint [7]
0
0
Baseline up to 6 years
Query!
Secondary outcome [8]
0
0
Change from Baseline in N-terminal-pro-hormone Brain Natriuretic Peptide (NT-proBNP)
Query!
Assessment method [8]
0
0
Change from baseline in NT-proBNP according to non-invasive criteria will be assessed as per the low (<300 nanogram per liters [ng/l]), intermediate (300-1400ng/l), and high-risk category (>1400 ng/l).
Query!
Timepoint [8]
0
0
Baseline up to 6 years
Query!
Secondary outcome [9]
0
0
Time to Worsening in WHO FC
Query!
Assessment method [9]
0
0
Time to worsening in WHO FC will be reported.
Query!
Timepoint [9]
0
0
Up to 6 months
Query!
Secondary outcome [10]
0
0
Change from Baseline in the Number of low-risk Noninvasive Criteria Based on WHO FC, 6MWD, and NT-proBNP
Query!
Assessment method [10]
0
0
Change from baseline in the number of low-risk noninvasive criteria based on WHO FC, 6MWD, and NT-proBNP will be reported.
Query!
Timepoint [10]
0
0
Baseline up to 6 years
Query!
Secondary outcome [11]
0
0
Time to all-cause Death Based on the Number of low-risk Noninvasive criteria Based on WHO FC, 6MWD, and NT-proBNP
Query!
Assessment method [11]
0
0
Time to all-cause death based on the number of low-risk noninvasive criteria based on WHO FC, 6MWD, and NT-proBNP will be reported.
Query!
Timepoint [11]
0
0
Up to 6 years
Query!
Secondary outcome [12]
0
0
Change from Baseline in Number of Participants Within Each Overall Risk Category (Low, Intermediate, or High) According to the Noninvasive Criteria
Query!
Assessment method [12]
0
0
Change from baseline in number of participants within each overall risk category (low, intermediate, or high) according to low-risk non-invasive criteria will be assessed as per the following parameters: WHO FC- low (I, II), intermediate (III), and high-risk category (IV); 6MWD- low (> 440m), intermediate (165-440m), and high-risk category (< 165m), and <165m; and NT-proBNP- low (<300ng/l), intermediate (300-1400ng/l), and high-risk category (>1400 ng/l).
Query!
Timepoint [12]
0
0
Baseline up to 6 years
Query!
Secondary outcome [13]
0
0
Change from Baseline in Number of Participants Within Each Overall Risk Category (low, Intermediate, or High) According to Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 1 Variables
Query!
Assessment method [13]
0
0
Change from baseline in number of participants within each overall risk category (low, Intermediate, or High) according to REVEAL Lite 1 Variables will be reported. The REVEAL Lite 1 variables risk calculator determines the risk status, and the scores (ranges from 0 to 19) can be defined as: low risk as a score of less than or equal to (<=) 6, intermediate risk as a score of 7 or 8, and high risk as a score of greater than or equal to (>=) 9 for the survival rates.
Query!
Timepoint [13]
0
0
Baseline up to 6 years
Query!
Secondary outcome [14]
0
0
Change from Baseline in Number of Participants Within Each Overall Risk Category (low, Intermediate, or High) According to REVEAL Lite 2 Variables
Query!
Assessment method [14]
0
0
Change from baseline in number of participants within each overall risk category (low, Intermediate, or High) according to REVEAL Lite 2 Variables will be reported. The REVEAL Lite 2 variables risk calculator determines the risk status, and the scores (ranges from 1 to 14) can be defined as: low risk as a score of <= 5, intermediate risk as a score of 6 or 7, and high risk as a score of >= 8 for the survival rates.
Query!
Timepoint [14]
0
0
Baseline up to 6 years
Query!
Secondary outcome [15]
0
0
Time to all-cause Death Based on the Risk Category Determined by the Noninvasive Criteria
Query!
Assessment method [15]
0
0
Time to all-cause death based on the risk category determined by the noninvasive criteria will be reported.
Query!
Timepoint [15]
0
0
Up to 6 years
Query!
Secondary outcome [16]
0
0
Time to all-cause Death Based on the Risk Category Determined by the REVEAL Lite 1
Query!
Assessment method [16]
0
0
Time to all-cause death based on the risk category determined by the REVEAL Lite 1 will be reported.
Query!
Timepoint [16]
0
0
Up to 6 years
Query!
Secondary outcome [17]
0
0
Time to all-cause Death Based on the Risk Category Determined by the REVEAL Lite 2
Query!
Assessment method [17]
0
0
Time to all-cause death based on the risk category determined by the REVEAL Lite 2 will be reported.
Query!
Timepoint [17]
0
0
Up to 6 years
Query!
Secondary outcome [18]
0
0
Risk Assessment Strategies for Clinical Worsening or Death
Query!
Assessment method [18]
0
0
The assessment of risk category for clinical worsening and death will be assessed by the following 3 risk assessment strategies: number of low-risk noninvasive criteria based on WHO FC, 6MWD, and NT-proBNP.
Query!
Timepoint [18]
0
0
Up to 6 years
Query!
Secondary outcome [19]
0
0
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by Symptoms and Impact Questionnaire for Use in Clinical Practice (SYMPACT-CP) Questionnaire
Query!
Assessment method [19]
0
0
A modified version of the PAH-SYMPACT for Use in Clinical Practice (SYMPACT-CP), has been created for use in routine clinical practice, as an assessment to support symptom monitoring and guide treatment decisions by healthcare providers. In the SYMPACT-CP, the 24-hour recall period for the oxygen use item and the 11 symptoms items have been modified to a 1-week recall period. The SYMPACT-CP also includes 11 impact items (with a 1-week recall period). This modification was made with the intention of administering the questionnaire at a single timepoint.
Query!
Timepoint [19]
0
0
Baseline up to 6 years
Query!
Secondary outcome [20]
0
0
Change from Baseline in Health Related Quality of Life Assessed by European Quality of Life (EuroQoL) Group, 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)
Query!
Assessment method [20]
0
0
The EQ-5D-5L is an instrument to measure health-related quality of life consisting of a descriptive system and visual analogue scale (VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of perceived problems (1 indicating no problem, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems, 5 indicating extreme problems). Participant selects an answer for each of 5 dimensions considering the response that best matches his or her health "today". The responses to the 5 dimensions are used to compute a single score ranging from 0 (worst health state) to 100 (better health state) representing the general health status of the individual.
Query!
Timepoint [20]
0
0
Baseline up to 6 years
Query!
Secondary outcome [21]
0
0
Change from Baseline in Health-Related Quality of life Status as Assessed by 36-item Short-Form Health Survey (SF-36) v2 Acute Questionnaire
Query!
Assessment method [21]
0
0
The SF-36 v2 acute questionnaire is a 36-item short form survey used to assess the participant's quality of life. In the SF-36 v2 Acute Questionnaire, participants are instructed to rate their health and capacity to perform activities of daily living in eight domains including physical functioning, physical role limitations, bodily pain, general health, vitality, social functioning, emotional role limitations, and mental health during the last week. The scores range from 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
Query!
Timepoint [21]
0
0
Baseline up to 6 years
Query!
Secondary outcome [22]
0
0
Change from Baseline in PAH-specific Medication Adherence as Assessed by Morisky Medication Adherence Scale-8 (MMAS-8) Score
Query!
Assessment method [22]
0
0
The MMAS-8 is commonly used in standard clinical practice and a validated measure of treatment adherence. The MMAS-8 includes 8 questions assessing the extent of adherence or nonadherence and reasons for non-adherence.
Query!
Timepoint [22]
0
0
Baseline up to 6 years
Query!
Secondary outcome [23]
0
0
Change from Baseline in Medication Adherence Questions of each Prescribed PAH Therapy Class
Query!
Assessment method [23]
0
0
Change from baseline in medication adherence questions of each prescribed PAH therapy class will be reported.
Query!
Timepoint [23]
0
0
Baseline up to 6 years
Query!
Secondary outcome [24]
0
0
Change from Baseline in PAH-specific Medication Adherence as Assessed by Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire
Query!
Assessment method [24]
0
0
The PAH-SYMPACT questionnaire, applicable only for participants who enrolled in the PAH-SYMPACT substudy, is a PRO instrument and composed of 2 parts: the symptoms part and the Impacts part. There is no total symptom score; the 2 domains are: cardiopulmonary symptoms and cardiovascular symptoms. The Impacts part has 2 domains: Physical Impacts Domain and Cognitive/Emotional Impacts Domain which contain 7 and 4 items, respectively. Each item has 5-point Likert response scale (0=not at all, 1=mild, 2=moderate, 3=severe, and 4=very severe). The mean individual weekly symptom item scores are aggregated by domain, with the sum then being divided by the number of symptom items in the respective domain. This leads to the average weekly domain score ranging from 0-4 for each participant with higher scores indicating greater symptom severity or worse impact.
Query!
Timepoint [24]
0
0
Baseline up to 6 years
Query!
Secondary outcome [25]
0
0
Change from Baseline in Patient Global Assessment of Disease Severity (PGA-S) of PAH
Query!
Assessment method [25]
0
0
Change from baseline in PGA-S of PAH will be reported. It includes severity of PAH symptoms, such as, none, mild, moderate, severe and very severe.
Query!
Timepoint [25]
0
0
Baseline up to 6 years
Query!
Secondary outcome [26]
0
0
PAH Symptoms and Impact using SYMPACT-CP Questionnaire
Query!
Assessment method [26]
0
0
PAH symptoms and impact using SYMPACT-CP questionnaire will be reported.
Query!
Timepoint [26]
0
0
Baseline up to 6 years
Query!
Eligibility
Key inclusion criteria
- Symptomatic pulmonary arterial hypertension (PAH) in any PAH subtype
- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to or at
the index date fulfilling all of the criteria below: a) Mean pulmonary artery pressure
greater than (>) 20 millimeters of mercury (mm Hg), and b) Pulmonary artery wedge
pressure or left ventricular end diastolic pressure less than or equal to (<=) 15 mm
Hg, and c) Pulmonary vascular resistance greater than or equal to (>=) 3 Wood Units
(that is, >= 240 dynes seconds per centimeters penta [dyn·sec/cm^5])
- Participant satisfies either a or b: a) Newly initiating 1 or more PAH therapy(ies)
(as monotherapy or add-on therapy) at index date. These newly initiated PAH therapies
should not have been used within 3 months of the index date; b) Taking macitentan 10
milligrams (mg) therapy (as monotherapy or in combination) with no changes in PAH
therapy for within 3 months prior to the index date
- All mandated assessments must be performed and recorded at the baseline visit before
the initiation of the new PAH therapy at the index date or enrollment in the study.
- For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy
only: Participants initiating any endothelin receptor antagonist (ERA) or
phosphodiesterase-5 inhibitor therapies at index date or at therapy change must
provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give
consent for the optional PAH-SYMPACT substudy will not exclude a participant from
participation in the main study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Participants enrolled in any interventional clinical trial with an investigational
therapy in the 3-month period prior to index date
- Currently enrolled in an observational study sponsored or managed by a Janssen company
- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] <70%; and FEV1 <60% of predicted after
bronchodilator administration) in participants with a known or suspected history of
significant lung disease, as documented by a spirometry test performed within 1 year
prior to screening
- Presence of moderate or severe restrictive lung disease (for example, total lung
capacity or FVC <60 percent [%] of normal predicted value) in participants with a
known or suspected history of significant lung disease, as documented by a spirometry
test performed within 1 year prior to screening
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/10/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/12/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
227
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Illinois
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Iowa
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Mexico
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Pennsylvania
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Rosario
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Belo Horizonte
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Botucatu
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Porto Alegre
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Sao Paulo
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Alberta
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Beijing
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Chengdu
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Shanghai
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Bonn
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Milano
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Pavia
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Rome
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Okayama
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
Busan
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Incheon
Query!
Country [32]
0
0
Korea, Republic of
Query!
State/province [32]
0
0
Seoul
Query!
Country [33]
0
0
Malaysia
Query!
State/province [33]
0
0
Kuala Lumpur
Query!
Country [34]
0
0
Netherlands
Query!
State/province [34]
0
0
Amsterdam
Query!
Country [35]
0
0
Netherlands
Query!
State/province [35]
0
0
Nieuwegein
Query!
Country [36]
0
0
Netherlands
Query!
State/province [36]
0
0
Rotterdam
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Kraków
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Lublin
Query!
Country [39]
0
0
Puerto Rico
Query!
State/province [39]
0
0
Guaynabo
Query!
Country [40]
0
0
Singapore
Query!
State/province [40]
0
0
Singapore
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
Cardiologia
Query!
Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Majadahonda
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Santander
Query!
Country [44]
0
0
Sweden
Query!
State/province [44]
0
0
Goeteborg
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
London
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Newcastle upon Tyne
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Papworth Everard
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Actelion
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is designed to describe pulmonary arterial hypertension (PAH) participants in
terms of their clinical characteristics, therapies used, disease progression, and outcomes
(example, death, hospitalization, risk category for predicted mortality risk, and
patient-reported outcomes [PROs]) in real-world clinical practice. This study will collect
high-quality real-world data that may be used as a stand-alone dataset or in combination with
other studies to address relevant research questions (example, serve as an external control
dataset to another study) to support development and access to PAH therapies, as well as to
contribute to the knowledge base of PAH through publications.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04955990
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Actelion Clinical Trial
Query!
Address
0
0
Actelion
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04955990
Download to PDF